Recall Z-0630-2024— Keystone Industries
Class II · Ongoing
Class II FDA medical device recall by Keystone Industries, initiated 2023-11-20. It names one FDA 510(k) clearance: K203000. Product: KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, repositioners, and retainers Item No.: 4220011. Reason: Keyprint Keysplint Hard Clear 1 kg resin bottles were inadvertently packaged with the wrong Instructions for Use. Keysplint Hard Clear were placed inside a zip lock bag along with KeySplint Soft Instructions for Use (IFU)..
- Recalling firm
- Keystone Industries
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-11-20
- Firm location
- Gibbstown, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, repositioners, and retainers Item No.: 4220011
Reason for recall
Keyprint Keysplint Hard Clear 1 kg resin bottles were inadvertently packaged with the wrong Instructions for Use. Keysplint Hard Clear were placed inside a zip lock bag along with KeySplint Soft Instructions for Use (IFU).
Data sourced from openFDA. This site is unofficial and independent of the FDA.